Canada: New fees came into force on 1 April 2020
USA: Ban on electrical stimulation devices used for self-injurious or aggressive behaviour
USA: Class II classification for HIV drug resistance genotyping assays using next generation sequencing technology
USA: HIV serological/nucleic acid diagnostic and supplemental tests to be classified into Class II (special controls)
USA: Certain hepatitis C virus antibody assays proposed for reclassification into Class II
USA: Proposed reclassification of nucleic acid-based HCV RNA assay devices
USA: Criteria used to establish device eligibility in 3P510k Review Program are subject of new guidance
USA: Developing and labelling in vitro companion diagnostics for a specific group of oncology therapeutic products
USA: Final guidance released on non-binding feedback after certain FDA device establishment inspections
USA: Guidance on 510(k) submissions for peripheral vascular atherectomy devices
USA: Revised guidance on preparing 510(k) submissions for electrosurgical devices for general surgery
USA: Recommendations for bone anchor 510(k) submissions clarified in final guidance
USA: Guidance released on requests for appeals of significant decisions
USA: Performance criteria drafted for soft (hydrophilic) daily wear contact lenses
USA: Guidance drafted on arthroscopy pump tubing sets intended for multiple patient use
USA: Proposed labelling changes for laparoscopic power morcellators
USA: Response due dates for marketing applications are extended by 60 days
USA: FDA launches voluntary eSTAR Pilot to improve 510(k) submissions and reviews
USA: Modifications to the list of US FDA-recognised standards
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